Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03819361|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2019
Last Update Posted : April 29, 2021
Obstructive sleep apnea (OSA) is a highly prevalent sleep-disordered breathing disease, caused by recurrent episodes of partial or complete collapse of the upper airway during sleep, resulting in intermittent hypoxia, fragmented sleep, fluctuations in blood pressure, and increased sympathetic nervous system activity. A single-night sleep study (i.e. respiratory polygraphy or polysomnography) is currently considered to be the gold standard for diagnosing OSA. However, recent studies suggest a significant intra-individual night-to-night variability of respiratory events, leading to the hypothesis that one single-night study might not reflect an accurate picture of the disease.
Part A: Patients with suspected obstructive sleep apnea, referred to our clinic, undergo the regular diagnostic procedure recommended by the current guidelines. In addition to the in-hospital single-night sleep study, these patients will perform 14 nights of pulse-oximetry at home. By computing and analysing sensitivity and specificity of every additional night, the investigator will answer the questions how many nights of sleep monitoring by home oximetry are necessary to diagnose OSA reliably, and how longitudinal sleep monitoring could reduce the number of false-negative and false- positive results compared to the in-hospital single-night study.
Part B: Based on the patients' data of part A, the investigator will develop a questionnaire and present anonymized cases to experts in the field of sleep medicine. Thereby, the investigator will evaluate if the additional information of repeated nocturnal pulse-oximetries changes the experts' decision making regarding diagnosis and treatment of OSA.
In a second step, the investigator will perform a classical Delphi study with a panel of experts in sleep medicine to establish consensus on repeated sleep studies and how they should be used for diagnosis and treatment in patients with suspected OSA.
|Condition or disease||Intervention/treatment|
|Obstructive Sleep Apnea||Diagnostic Test: pulse-oximetry|
|Study Type :||Observational|
|Actual Enrollment :||130 participants|
|Official Title:||Effect of Longitudinal Sleep Monitoring on Diagnosis and Treatment Decision in Patients With Suspected Obstructive Sleep Apnea (ELSA)|
|Actual Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2022|
Diagnostic Test: pulse-oximetry
Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich
- The accuracy of 1-13 nights of pulse-oximetry compared to the mean ODI of 14 consecutive nights [ Time Frame: 14 nights of pulse-oximetry ]"Sensitivity" and "specificity" for every additional night will be assessed
- Decision making of a panel of experts in the field of sleep medicine regarding diagnosis and severity of OSA (no OSA, mild, moderate, severe) with/without the additional information of longitudinal sleep monitoring [ Time Frame: 14 nights of pulse-oximetry ]
- ODI variability measured in 14 consecutive nights of pulse-oximetry [ Time Frame: 14 nights of pulse-oximetry ]
- Change of OSA severity class (no OSA, mild, moderate, severe OSA) during 14 nights of pulse-oximetry due to ODI variability [ Time Frame: 14 nights of pulse-oximetry ]
- Change of OSA severity class (no OSA, mild, moderate, severe OSA) diagnosed by in-hospital single-night sleep study vs repeated measurements by pulse-oximetry [ Time Frame: 14 nights of pulse-oximetry ]
- Decision making of a panel of experts in field of sleep medicine regarding treatment decisions (CPAP yes/no) with/without the additional information of longitudinal sleep monitoring [ Time Frame: 14 nights of pulse-oximetry ]
- Establish consensus on repeated sleep studies and their use in diagnosis and treatment in patients with suspected OSA [ Time Frame: 14 nights of pulse-oximetry ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819361
|University Hospital Zurich|
|Zürich, Zurich, Switzerland, 8091|
|Principal Investigator:||Malcolm Kohler, Prof. Dr. med.||University of Zurich|